Plasma ctDNA in Patients Undergoing Diagnostic Colonoscopy

Colon Cancer Clinical Trial

Official title:

Determination of the Utility of Plasma Circulating Tumor DNA (ctDNA) Measurements for the Detection of Colon Cancer in Patients Undergoing Diagnostic Colonoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02665299
• Other study ID #: Pathway Genomics 005
• Status: Completed
• Phase: N/A
• First received: January 22, 2016
• Last updated: August 16, 2017
• Start date: January 2016
• Est. completion date: August 2017

Study information

• Verified date: August 2017
• Source: Pathway Genomics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

When the DNA inside of human cells undergoes certain alterations (mutations), the cells may develop into a cancer. The cancer cells may shed this DNA into the blood stream. This circulating tumor DNA (ctDNA) can be detected by very sensitive, specialized laboratory tests. Measurement of ctDNA has been shown to be useful for following patients with known cancer. It has also been found in the circulation of some patients with early stage cancer. The purpose of this study is to examine blood specimens for the presence of ctDNA in individuals without known cancer who are scheduled to undergo a screening or diagnostic colonoscopy in order to see if the ctDNA test can detect a cancer or precancerous condition at a very early stage before the patient becomes symptomatic. The results of this study should help define the role of ctDNA in the detection of early stage colon cancer and to define how sensitive it is (i.e. how well it picks up cancer when it is present) and how specific it is (i.e. how often is ctDNA found in patients with benign diseases or no abnormalities).

Description:

After the participants have undergone the informed consent process, they will have 30 milliliters (approximately two tablespoons) of blood drawn. This will be done prior to their scheduled screening or diagnostic colonoscopy. If the patient has indicated a desire to receive the results of their test, they will receive a written description, as will their primary care physician. The patients will be contacted yearly for up to 5 years by the study staff to learn whether they have been found to have a diagnosis of colon or other cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: August 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria: .

• 18 years of age or older who are scheduled to undergo a screening or diagnostic colonoscopy by Dr. Phillip Fleshner

Exclusion Criteria:

• Prior history of cancer excluding basal cell carcinoma of the skin

Related Conditions & MeSH terms

• Adenoma
• Colon Adenomas
• Colon Cancer
• Colon Polyps
• Colonic Neoplasms
• Colonic Polyps

Locations

Country	Name	City	State
United States	Pathway Genomics	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Pathway Genomics

Country where clinical trial is conducted

United States, 

References & Publications (1)

Perrone F, Lampis A, Bertan C, Verderio P, Ciniselli CM, Pizzamiglio S, Frattini M, Nucifora M, Molinari F, Gallino G, Gariboldi M, Meroni E, Leo E, Pierotti MA, Pilotti S. Circulating free DNA in a screening program for early colorectal cancer detection. Tumori. 2014 Mar-Apr;100(2):115-21. doi: 10.1700/1491.16389. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Utility of plasma ctDNA measurements to detect colon cancer or precancerous conditions.	Correlation between plasma ctDNA results and any pathology found at time of diagnostic colonoscopy. Determination of true positive, false positive and predictive values for using ctDNA measurements to detect colon cancer and precancerous conditions.	1 year
Secondary	Determination of incident rate of new colon or other cancers in patients who underwent initial measurement of ctDNA	Subjects will be contacted yearly to obtain follow-up information regarding the development of colon or other cancer in order to see if the initial ctDNA measurement detected the cancer before it became clinically apparent.	5 years